Explained: Management Responsibility in ISO 13485

After getting basic knowledge regarding Medical Device Files and, Control of Documents and Records, it’s time to explain what is the Management Reposnsability part in this standard.

Management Responsibility is about a leadership obligation to assist the people you manage. If leadership is done well, it will constantly provide high-quality medical devices. Within the medical device industry, every employee has some level of responsibility for the safety of the device, therefore, for patients and users of the devices provided by the organization.

There is a significant difference in the level of responsibility, and accountability, between the people who control the organization and the people who perform the daily work within the organization.

Managements commitment

In every organization a management structure is present and it classifies the personnel who is responsible for the control and supervision of the entire organization. Selected the management team will develop goals, the company’s policy, strategic plans, and make decisions on the direction of the business. These individuals are responsible to ensure that the Quality Management System is properly designed and performed to achieve the organization’s obligation. They need to confirm the safety of the patients and users of the medical device provided by their organization.

ISO 13485:2016 requires top management to participate in the implementation and maintenance of the Quality Management System. Management of the organization is meant to provide proof of its commitment to the development and implementation of the quality management system and maintenance of its effectiveness by:

• explaining to the organization the importance of meeting customer needs and applicable regulatory requirements form the quality policy

• ensuring that quality objectives are established

• leading management reviews

• ensuring the resources are available

• focusing on the customers’ requirements

Focus is always on customers

The quality has to be part of the organization’s culture. Management plays a critical role, and therefore they need to be involved and ready to lead. The moment decision-making management makes a mistake in their approach to true quality, it becomes difficult to reconstruct it. The major part of a healthy quality culture is focused on the customers. For medical device companies, the customers are patients and users of medical devices and technologies designed, developed, and manufactured by their organization. Organizations should always do what is best for their patients and that should become the guiding force for true quality.

How quality objectives should be defined? They are a base for monitoring and measurement, so certain KPI should be established on objectives, to be able to measure. But, I have a problem to identify them quantitatively. For example, objective: customer satisfaction. How to set KPI?